AllTrials asked the ABPI to respond to a series of questions about its commissioned study "Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe.”

The questions - posted on the AllTrials website - about the study were:‘We are asking the ABPI about the methodology the exclusion of incomplete trials from the denominator, decisions to exclude trials on combination products and vaccines and those conducted by ‘third party institutes’.

Each question has been answered below:

1. Exclusion of incomplete trials

The study was designed to assess disclosure of results. For results to be disclosed, the trial had to be complete; therefore trials marked in the various sources as ‘complete’ were included.

On the occasions that the completion date was missing or unclear, disclosure of results were not assessable within twelve months of a completion date. They would however still be assessable for disclosure by 31 January 2013 and were included if disclosed. Interim results from long-term follow-up studies were also included in our assessment (as separate trials, adding to the evidence base) if they were specifically cited in the EPAR and/or registered under a separate registry identifier.

2. Exclusion of trials on combination products or vaccines

The study set out to explore results relating to trials supporting new medicines, that is new active substances (NAS) recently approved by the EMA for use in the treatment of patients. Therefore, our focus was solely on NAS.

Exclusions were:

Generic product approvals and combination products, as the latter are normally based upon active substances which have been previously approved separately at earlier time points.

Vaccines, which are generally used in healthy subjects and not patients, therefore these trials would have fallen outside the scope of this study, which included only trials conducted in patients.

3. Exclusion of studies carried out by ‘third party institutes’

The study set out to assess the situation relating to disclosure of clinical trial results by the pharmaceutical industry. As such, all completed trials where the main sponsor and/or the responsible party (according to the registry or other source) was a pharmaceutical company were included.

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